1.
Description
of the Vitalograph SPIROTRAC

Vitalograph Spirotrac is a Microsoft
Windows based
computerized Spirometry system that is intended for use by medical
professionals who are trained in respiratory and lung function testing.
The
Spirotrac application interfaces with the Vitalograph Pneumotrac,
Vitalograph
In2itive, Vitalograph Alpha, Vitalograph Alpha Touch, Vitalograph 2120,
Vitalograph 2160, Gold Standard, Intrac and asma-1 Spirometry devices. In addition to
spirometry
testing, Spirotrac also includes Pulse Oximetry, Challenge Testing,
Blood
Pressure, Six Minute Walk Test, 12-lead ECG and Audiometry
modules.

Spirotrac is intended for use in
occupational health
centres, hospitals, pharmaceutical research centres, physicians' and
GPs'
offices, and wherever else advanced PC-based spirometry or cardio
respiratory
monitoring is required. Spirotrac is not intended for use for vital
signs
monitoring in a critical-care setting.

Spirotrac
provides a system for adding and
recalling subjects, performing relevant tests, saving the results to
its own
database and printing reports.

To launch the Help file:

1.Select User
Training Manual
from the Help
menu

Information about the software can be
obtained from the
‘About’ box. This information can be used if any queries are made to
Vitalograph or a service agent.

To
access the ‘About’ box:

SelectAbout
from the Help
menu

1.1.
Indications for Use

The Vitalograph Model 7000 Spirotrac
is intended for use by
or on the order of a physician in a hospital or clinic setting. The
product is
designed for use on both adult and pediatric patients. The device is a
PC based
software application which is intended to be used as a spirometer or
connect to
compatible devices to acquire, view, store and print the device output.

2. BUTTONS
AND ICONS USED IN SPIROTRAC

The following buttons are visible on
the main toolbar:

Create a New Subject

VC
Testing

FVC
Testing

Post
Mode Testing

PCF Test

MVV Test

Inhaler Test

Challenge
Test

12-Lead
ECG

Recall/View
12-Lead ECG

Audiometry

Recall/View Audiometry

Pulse
Oximetry Testing

Six Minute Walk Test

Measure
Blood Pressure Test

Print
current session report

Print
current session report to PDF

Send
sessions to over-read

Perform
an Accuracy Check on the Vitalograph
Pneumotrac

3. Features
of the Vitalograph SPIROTRAC

Vitalograph Spirotrac offers a number
of sophisticated
features, summarised as follows:

Ability to re-open and continue VC, FVC, Audiometry testing on same
calendar day

Name change on Korean predicted set

Ability to disable print of rejected tests

Change to report type selection- Best Summary (Prints ATS/ERS best test), All Tests (Prints up to
a max of 8 tests in test order)

Ability to select parameters printed on the standard one page
report

Add pre-session quality information to the standard post report

New configurable option to set the mm/mV ratio on the ECG report

Ability to trend audiometry data

Enhanced display of ear protection results

Enhanced
selection of report template for Audiometry results

Re-label
of Field Walk Test to Six Minute Walk Test (6MWT)

Ability for user to configure
Spirotrac to automatically return unsolicited messages to EMR for
Spirometry

Ability to include
subject data when exporting data from Spirotrac

4. Getting
the Vitalograph SPIROTRAC Ready
For Use

Note:Vitalograph
commits to providing software that is virus-free. Vitalograph assumes
no
liability for the security of customer computer systems. Any
computer
connected to the local area network {LAN} or internet is at risk of the
system
being compromised. Vitalograph recommends that customers take
appropriate
measures to mitigate such risk including installation and maintenance
of
anti-virus software and firewall(s) on IT systems to prevent intrusion
and
protect those systems, in line with customer’s internal IT policies.

4.1Loading
the Spirotrac Software on a PC

Note:Spirotrac must be
installed by a User with Administrative
privileges on a PC.The Vitalograph COMPACT is supplied with a full
installation
of Spirotrac including all device drivers and a test station licence.

To install Spirotrac, do the
following:

Place the Spirotrac DVD in the
DVD/CD-ROM disk drive. After a moment, the installer application will
automatically run.

When the installer starts click Install
Spirotracto
start the installation of Spirotrac.

Click the Next
button to begin the installation.

Read the Licence Agreement and if
you are satisfied with the terms agree to it. If you do not, the
installation will not continue.

Click the Next
button.

If necessary, make changes to the
install location by selecting the Browse button. Click the Nextbutton
when finished.

The files are copied to the
selected drive and directory. An error message is displayed if there is
insufficient space on the drive. If this occurs, you should click on
the OK
button. Create space by deleting or backing up files and then start
installing again from step 1.

A virtual PDF printer driver is
installed onto the system. This allows the user to select this printer
when printing, which allows the user to print to an Adobe Acrobat
compatible PDF file.

When the installation has
completed, a message is displayed on the screen informing the user of
same. Click on the Closebutton.

The program name appears in the START menu under Start->
All Programs -> Vitalograph ->Spirotrac along
with a Shortcut icon which is placed on the desktop.

Setup Spirotrac by starting the
Spirotrac application. The Spirotrac Setup is displayed.

The user is prompted to enter the
Device Serial Number of a Vitalograph device to be used with Spirotrac,
and their email
address. Entering a valid Device Serial Number will allow Spirotrac to
be used
as a local test station. Alternatively click Skip
to use Spirotrac only as a local review station.

To activate Spirotrac for use on
a network as a multi-user review station, enter the Network Licence Key
exactly as provided in the ‘If you have
purchased an additional Network Licence Key, enter this below’
field.

Click Activate to
move to the next step of the setup, or Cancel
to cancel setup.

For installations on a PC, a
Database
Connection Details form is displayed. Ensure details are correct. If
the
current pc is a client pc, enter the server name/instance of the
database.
Select Continue and the database is
created.

Setup the Spirotrac System Administrator user
when prompted. The id for this user will be ‘Administrator’ and the
password
which is case sensitive must be at least 6 characters in length. A
checkbox is provided
for the user to setup Spirotrac without user logon capability, if
required. Note:It
is recommended
that the user logon capability is enabled to ensure security of subject
data.
User shall always be required to logon when using a network database.

You
will have the option to set-up other users
at this stage. To set-up another user, select the ‘Add User’ button or
users
can be added later from within Spirotrac if you wish, so select the
‘Continue’
button.

The
user will then be prompted to set-up the
Institution and Department details, and to register Spirotrac.

Next,
user is prompted to log on to the
Spirotrac application. (See Starting Spirotrac for the first time for
next
steps).

Note: The user may
select to cancel out of the set-up at any time. However, as the above
details
are required prior to launching Spirotrac, the application will not be
launched
until all the details are provided. Only then will Spirotrac actually
launch.
Once, Spirotrac is launched, checking the configuration settings is
recommended,
to ensure that user preferences are set-up as required.

Additional documentation is
available on the CD as support. These can be found under the following
headings
on the installer: ‘Release Notes’, ‘Spirometry Guidelines’ and ‘Other
Manuals’.

4.2.2
How to create a user database

b. Click
the Select tab, select the
new
database and click Apply. Note:
You shall
be prompted to
restart Spirotrac.

c. Enter
Administrator User details.

d. Enter
Username and Password and select Continue.

Note: Selecting the disable
user logon option here will allow the
device to be used with reduced security, so is not recommended.

e. Enter
institution details and select Continue.

f. Enter
department details and select Continue.

g. Spirotrac
software will open to
show the newly created user database (no data).

4.2.3
Subsequent Logon

User
ID will be pre-populated
with the user ID
of the last person who logged into the COMPACT. If required,
replace this
with your (current user) ID.

The COMPACT
will open Spirotrac when login is successful.

4.3
Network Database Installation

4.3.1
Network Database Installation on a PC during first setup

If
the user has not previously entered a valid
Network Licence Key the Server Name field will be prepopulated with the
value
‘localhost’ and will not be editable.

If
the user has previously entered a valid
Network Licence Key the user will be able to enter the Server Name of
the SQL
Server 2008 R2 host. Enter the SQL Server 2008 R2 Instance name if
required
(default SQLEXPRESS). Consult
with your SQL Server Database Administrator for these settings.

If
the Database already exists Spirotrac will
simply connect to and use this Database.

If
the Database does not exist Spirotrac will
create this Database automatically. The User must have the appropriate
privileges to perform this action. Consult
with your SQL Server Database Administrator for these privileges.

If
a Database from a previous version of
Spirotrac exists, Spirotrac will automatically migrate the data to the
current
version of the Database.

The
user will be prompted to supply the
Administrator password. This account should later be used to setup
other
Spirotrac users.

The
user will be prompted to add other users to
Spirotrac (optional).

The
user will be prompted to supply details of
the Institution.

The
user will be prompted to supply details of
the Department.

Note: At
any point during the Spirotrac Setup
Wizard the User may click the Setup
Laterbutton.
The Wizard will pick up from where
it left off during next run.

4.3.2
Network Database Setup on a
PC after initial
setup or on a Vitalograph COMPACT.

In order to use a network database with
Spirotrac,
a network licence key is required. This may be obtained from technical
support
+44 1280 827177 or email tech.support@vitalograph.co.uk. In order to
activate
your network licence, follow the instructions in the Licence
Management section.

To
configure Spirotrac to use a network database, once the network db has
been
setup (Consult with your SQL Server Database Administrator), do the
following:

Select
Tools -> Database Management

Select/Enter
the name or I.P.
address of the SQL Server host

Select/Enter
the SQL Server
instance name

Select
the desired Authentication
mode from the drop down list and enter user login and password if SQL
authentication

Select the required
database from
the list and select Apply.

4.3.2.1
Connecting to a
network database with Vitalograph Spirotrac on a Compact device

The
Vitalograph COMPACT is supplied with a full installation of Spirotrac,
including all device drivers and a test station licence. As with a PC a
network
licence key is required (see above)

To
gain access to a network database from the compact device you need to
ensure
the sql server:

accepts
remote connections

allows
SQL Server Authentication

has
a sql server login that uses SQL Server Authentication, with a strong
password,
which has access to the Spirotrac database

Consult with your
SQL Server Database
Administrator

To use
this network database from the compact device you need to

Select Tools
-> Database
Management

Select/Enter the name or I.P.
address of the SQL Server host

Select/Enter the SQL Server
instance name

Select SQL
Server Authentication from
the Authentication drop down list

Enter the sql server user login
and password

Select the required database from
the list and select Apply

4.4
Installing the Vitalograph
Pneumotrac/Intrac USB drivers on a PC

Note:
These drivers are
installed automatically as part of the
Spirotrac Installation.

To install Vitalograph Pneumotrac
USB drivers manually, do the following:

Place the Spirotrac CD in the
DVD/CD-ROM disk drive. After a moment, the installer application will
automatically run.

When the installer starts clickInstall
USB Pneumotrac

A WinZip self-extracting file
will automatically execute and display the Vitalograph
USB Pneumotrac Installer dialog – click the
Next
button.

The USB Pneumotrac drivers will
be installed at this point. Click the Finish
button.

4.5.
Installing the Vitalograph In2itive and Alpha
USB drivers on a PC

Note:
These drivers are
installed automatically as part of the
Spirotrac Installation.

To install Vitalograph In2itive
and
Alpha USB drivers manually, do the following:

Make sure the Spirotrac CD is
inserted in the CD/DVD drive of the PC. If not, insert it now. (Note: When the CD is
inserted, the installation wizard will start.)

Click on the Install
USB Device Driveroption.
The USB drivers will be installed at this point. Click the Finish button.

Connect one end of the USB cable
into an available USB port on the PC.

Power Up the Vitalograph
In2itive/Alpha device.

Connect to the other end of the
USB cable into the Vitalograph In2itive/Alpha device.

The PC will detect that new
hardware has been connected and the ‘Found New Hardware’ installation
wizard shall be displayed. This dialog will ask, “Can
Windows connect to Windows Update to search for Software?”
Select “No,
not this time”
and click theNextbutton.

Follow the default options on the
screen until you are asked where to install your hardware from and
choose Install
the software automatically–
click the Next
button.

You may be presented with an
information dialog in relation to Windows Logo checks. Choose Continue
Anyway on this screen.

The In2itive/Alpha drivers will
be installed at this point and you will be presented with a Finishbutton.
Click this button.

4.7.
Installing the drivers for the Nonin Pulse
Oximeter on a PC

Note:
These drivers
are installed automatically as part of
the Spirotrac Installation.

To install the drivers manually,
do
the following:

Make sure the Spirotrac CD is
inserted in the CD/DVD drive of the PC. If not, insert it now. (Note:
When the CD is inserted, the installation wizard will start. You can
close this)

Connect one end of the USB cable
into an available USB port on the PC.

When windows auto-detects new
hardware has been connected

The ‘Found
New Hardware’ installation wizard shall be displayed. This
dialog will ask, “Can
Windows connect to Windows Update to search for Software?”
Select “No,
not this time”and click the Next
button.

Follow the default options on the
screen until you are asked where to install your hardware from and
choose “Browse my computer for driver software”.When prompted for
“Search for driver software in this location:”, navigate to the
PulseOximetryDriver folder on the CD and click the Next
button.

When Windows does not auto-detect
new hardware,

Open Control
Panel and double-click the Add
hardware icon to run the hardware detection wizard.

When prompted by the 'Update
Driver Software' wizard, point to the PulseOximetryDriver folder
containing the drivers for the device and click the Next
button.

The drivers will be installed at
this point and you will be presented with a Finish
button. Click this button.

4.8.
Connecting the USB
Vitalograph Pneumotrac to
your PC

The following simple steps need to
be carried out to prepare the Vitalograph Pneumotrac for use.

For safety, it is recommended that the PC is fully
powered off before you start this procedure.

Plug one end of the USB cable
into an available USB port at the back of the PC (usually marked with
the symbol).

Plug the other end of the USB
cable into the USB port at the side of the Vitalograph Pneumotrac
(marked with the symbol).

If
you connect additional equipment (not produced by Vitalograph) to the
USB interface port, it must conform to VDE0750 Part 1-1 regulations and
to your EN specifications, e.g. EN60950 for data equipment, EN60601 for
medical equipment. Non-medical equipment must be kept outside the
patient environment i.e. any area in which intentional or unintentional
contact between the patient and parts of the system, or some other
persons touching parts of the system can occur. (Contact your
distributor if you have any queries.)

Unwrap the flowhead connection
tubing from its packaging and connect one end to the Vitalograph
Pneumotrac device. If the tubing is ribbed ensure that the ribbed side
of the tubing is connected to the ribbed half of the connector. If the
tubing is smooth it is shaped so that it will only connect one
way.

Unwrap the flowhead from its
packaging and connect the other end of the flowhead connection tubing
to it. If the tubing is ribbed ensure that the ribbed side of the
tubing is connected to the ribbed half on the flowhead connector. If
the tubing is smooth it is shaped so that it will only connect one
way. Note:
If flowhead connection tubing is connected
the wrong way round flows will be displayed as inverted on Spirotrac.

The Vitalograph Pneumotrac device
is now ready for use.

The USB driver must be installed
on the PC to begin testing. Refer to the USB driver instructions for
details.

Medical
Devices may be affected by cellular telephones and other personal or
household devices not intended for medical facilities. It is
recommended that all equipment used near the Vitalograph Pneumotrac
comply with the medical electromagnetic compatibility standard and to
check before use that no interference is evident or possible. If
interference is suspected or possible, switching off the offending
device is the normal solution, as is required in aircraft and medical
facilities.

4.9.
Connecting the Serial
Vitalograph Pneumotrac
to your PC

The following simple steps need to
be carried out to get the Vitalograph Pneumotrac ready for use.

For
safety, it is recommended that the PC is fully powered off before you
start this procedure.

Plug one end of the serial cable
into an available serial port at the back of the PC (usually marked
with the symbol). If the PC has a 25 pin
serial port connector use a 9 pin to 25 pin port adapter.

Plug the other end of the serial
cable into the serial port at the side of the Vitalograph Pneumotrac
(marked with the symbol).

If
you connect additional equipment (not produced by Vitalograph) to the
serial interface port, it must conform to VDE0750 Part 1-1 regulations
and to your EN specifications, e.g. EN60950 for data equipment, EN60601
for medical equipment. Non-medical equipment must be kept outside the
patient environment i.e. any area in which intentional or unintentional
contact between the patient and parts of the system, or some other
persons touching parts of the system can occur. (Contact your
distributor if you have any queries.)

Unwrap the flowhead connection
tubing from its packaging and connect one end to the Vitalograph
Pneumotrac device. If the tubing is ribbed ensure that the ribbed side
of the tubing is connected to the ribbed half of the connector. If the
tubing is smooth it is shaped so that it will only connect one way.

Unwrap the flowhead from its
packaging and connect the other end of the flowhead connection tubing
to it. If the tubing is ribbed ensure that the ribbed side of the
tubing is connected to the ribbed half of the flowhead connector. If
the tubing is smooth it is shaped so that it will only connect one way.
Note: If flowhead connection tubing is connected the wrong
way round flows will be displayed as inverted on Spirotrac.

The following simple steps need to
be carried out to get the Vitalograph 2120 ready for use.

Make sure that the PC is turned
off.

Connect the serial cable supplied
with the Vitalograph 2120 and following the instructions supplied with
it, ensure that the power supply is connected to it unless the battery
is already charged.

Connect the 9 pin ‘D’ serial
connector on the other end of the 2120 cable to the appropriate serial
‘COM’ port on the back of the PC.

4.11.
Connecting the Vitalograph In2itive and Alpha
to your PC or Vitalograph COMPACT

The following simple steps need to
be carried out to get the Vitalograph In2itive and Vitalograph Alpha
devices
ready for use.

For
safety, it is recommended that the PC is fully powered off before you
start this procedure.

Plug one end of the USB cable
into an available USB port on the PC/COMPACT (usually marked with
the symbol).

Plug the other end of the USB
cable into the USB port at the side of the Vitalograph In2itive/Alpha
(marked with the symbol).

If
you connect additional equipment (not produced by Vitalograph) to the
USB interface port, it must conform to VDE0750 Part 1-1 regulations and
to your EN specifications, e.g. EN60950 for data equipment, EN60601 for
medical equipment. Non-medical equipment must be kept outside the
patient environment i.e. any area in which intentional or unintentional
contact between the patient and parts of the system, or some other
persons touching parts of the system can occur. (Contact your
distributor if you have any queries.)

The Vitalograph In2itive/Alpha
device is now ready for use.

The In2itive/Alpha driver must be
installed on the PC to begin testing. Refer to the USB driver
instructions for details.

Medical
Devices may be affected by cellular telephones and other personal or
household devices not intended for medical facilities. It is
recommended that all equipment used near the Vitalograph Pneumotrac
comply with the medical electromagnetic compatibility standard and to
check before use that no interference is evident or possible. If
interference is suspected or possible, switching off the offending
device is the normal solution, as is required in aircraft and medical
facilities.

Note:
This equipment may
be affected by electromagnetic
interference. Also the Pneumotrac/In2itive/Alpha/2120 may affect other
electrical equipment in the close vicinity. If such effects are
suspected
either switch off the offending equipment or increase the distance
between the
affected equipment and that suspected of causing the interference, or
shorten
connecting leads.

1.Prior
to obtaining an ECG recording using the BT12 device and the Vitalograph
ECG
software, the PC/COMPACT running the ECG software and the BT12 device
must be
paired using a Bluetooth connection.

2.A
Bluetooth dongle must be plugged into the PC/COMPACT before starting
the ECG
software. Plug the Bluetooth dongle into an available USB slot on the
PC. Note:
Where the PC has integrated Bluetooth capability with the
Microsoft
Bluetooth stack, a Bluetooth dongle will not be required here.

3.Turn
on the ECG device. Select the ECG test button and the device should
automatically pair.

4.If
problems occur go to Tools-Options-ECG-Device
Configuration and select the Add/Pair
button. Spirotrac shall auto-detect available devices. After the device
BT12
has been found by Spirotrac, the serial number of the device is shown. Note:
The serial number shall be preceded with 'BT12v_SN:'
identifier.

5.Select
the serial number of the BT12 device you wish to pair with and then
click on OK. If the serial number
of the BT12
device is not displayed, this may be because it already paired
with
another PC/COMPACT. To clear prior BT12 device pairings, make sure the
device
is off and then press the device On/Off button and hold for 20 seconds
until a
double-beep is heard.

6.The
Bluetooth driver should ask for a PIN during the pairing. Enter the PIN
"1111" in the provided text field
and confirm by pressing the OK
button.

7.The
device is now connected and ready for operation.

4.15
Preparing the Wifi adaptor for use with the
Vitalograph COMPACT

Note:
Please see the manufacturer’s user instructions for more details.

The
following steps needs to be carried out in order to setup the COMPACT
device
for wireless networking:

1.Plug
the Wifi adapter into an available USB port on the COMPACT.

2.The
Wifi adaptor client manager will display in the bottom corner on screen.

3.Select
the Create Profile option

4.Next
select the setup method:

4.1.Select
Automatic Secure Setup to setup
automatically

4.2.Select
Advanced Setup for manual selection

5.Next
select the connection method:

5.1.Select
Connect manually to be presented
with
a list of wireless access points available.

2.Connect
the USB device containing the driver files to an available USB port on
the
COMPACT.

3.Select
Tools -> Administration ->
Install
Software.

4.Select
the required installer/self-extractor, then select Run
and follow the on-screen instructions/wizard as displayed.

4.17
Configuration Mode on the Vitalograph COMPACT Device

In
order for some settings to be available upon a restart of the COMPACT,
they
require the COMPACT to be in configuration mode when
configured. Examples
of these settings are: Adding a printer, Installing Software, Wifi
settings,
Timezone/Date/Time changes and pairing with ECG device.

To place
the COMPACT device into configuration mode, do the following:

1.Logon
as an Administrator user.

2.Select
Tools -> Administration -> Configuration Mode.

3.The
COMPACT will now re-start in configuration mode.

Note: When in configuration mode, testing is
disabled. In order to return to normal mode, select File -> Exit
and restart your COMPACT.

4.18.
Connecting the Gold Standard to
your PC

First check that the contents of the packaging correlate with what is outlined
on the contents label on the inside of the packaging carton.

The following simple steps need to
be carried out to prepare the Vitalograph Gold Standard for use.

For safety, it is recommended that the PC is fully
powered off before you start this procedure.

Plug one end of the USB cable
into an available USB port at the back of the PC (usually marked with
the symbol).

Plug the other end of the USB cable into the USB port at the rear of the
Vitalograph Gold Standard (marked with the symbol).

If
you connect additional equipment (not produced by Vitalograph) to the
USB interface port, it must conform to VDE0750 Part 1-1 regulations and
to your EN specifications, e.g. EN60950 for data equipment, EN60601 for
medical equipment. Non-medical equipment must be kept outside the
patient environment i.e. any area in which intentional or unintentional
contact between the patient and parts of the system, or some other
persons touching parts of the system can occur. (Contact your
distributor if you have any queries.)

Unwrap the breathing tube from its packaging and connect the flexible end of
the breathing tube to the Vitalograph Gold Standard device.

Insert a disposable bacterial viral filter (BVF) into the plastic adaptor at the
other end of the tubing.

Set the desired starting position using the Volume Adjustment Handle.

The Vitalograph Gold Standard device is now ready for use.

The USB driver must be installed on the PC to begin testing. Refer to the
USB driver instructions for details.

Note: Bacterial viral filters must be used to provide maximum protection against
the possibility of contamination and inter-subject cross infection during
testing.

5.
OPERATING VITALOGRAPH SPIROTRAC

5.1
Starting Spirotrac for the
first time

On starting
Spirotrac for the first time a Logon dialog is displayed prompting the
user for
their ID and password (These will have been set-up during
installation). SeeLogging
into Spirotrac.

5.2.
Start-up / Logon

Note: In order to use the application, Spirotrac
requires that the PC user adhere to one of the following:

User
must have full administrative rights on the
PC, or

User
must be added to the SQLServerMSSQLUser
group, or

User
must be added to the SQLServer’s
Security-Login with full read/write access to the SpirotracV database
(for
upgrades) and SpVDefault database.

5.2.1.
Logging into Spirotrac

Users who
have been successfully added to the Spirotrac software
(reference the Userssection)
will have
their own User ID and Password.

The logon screen will be
presented on start-up, prompting for User ID
and Password to be entered. For Network installations the Database
field will
be enabled allowing the user to select the server database.

The User ID will be pre-populated
with the User ID of the last person
who logged into the Spirotrac software application. If appropriate,
enter your
own User ID.

If the login is successful (your
user criteria is accepted by the
system), you will be presented with the Spirotrac software application
desktop.

If
the login is not successful (your user criteria is rejected by the
system), you will be presented with the Login screen again. Note: Spirotrac can be
configured to lock a user
out for a configurable time period on failure to logon after a
configurable
number of attempts.

If you wish to abort the login
process at this stage, click on the Cancel
button.

5.2.2.
Application Lock
(Autolock) / Unlock

Spirotrac will automatically lock
after defined periods of inactivity (The default is 45 minutes). Only
the
currently logged on user, or the Administrator user can unlock
Spirotrac.

1.Automatic application locking can
be configured to different time
intervals (Go to Tools -> Options -> General-Security to
configure
application lock timeout)

2.While Spirotrac is locked all
active windows & dialogs will be
hidden, they will be restored to their current state upon unlock.

4.Enter the reset passcode as
provided by Vitalograph which shall be
validated by Spirotrac prior to continuing.

5.To reset a user’s password:

a.Select the option to reset
password

b.Enter the user’s name (this must
match an existing user)

c.Enter and confirm the new
password (these must match)

6.To setup new user details:

a.Select the option to setup a new
user name and password

b.Enter the user’s name (this must
be a new user name)

c.Enter and confirm the password
(these must match)

7.Once the new user logon details
have been validated, Spirotrac will login
using these user details.

5.3.
Subject Management

5.3.1
Autogeneration of Subject ID’s

Each
subject created within
Spirotrac must be allocated a subject ID. Spirotrac can automatically
generate
the subject ID if required, at the time of subject creation.
Autogeneration of
subject ID’s is enabled by default.

5.3.2.
Creating a Subject

1.Select New
->
Subject in the File menu or click
the new
subject button on the main toolbar.

2.Enter details for each field as
follows: -

a.Subject
ID
- a unique number for each subject, this will be
generated automatically if autogeneration of subject ID’s is enabled,
but the
user may change this ID if required. This field is mandatory. Note 1: To create a new
subject, the Subject ID
is mandatory. All other details are optional. Note 2: On Swedish and
Norwegian variants,
Swedish and Norwegian ID formats are supported here.

b.Alternative
Subject ID - an alternative identifier for
the subject. It is
configurable as to whether this field is displayed or not (see Subject
Data
Setup).

c.First
Name
- the Subject's first name, can be up to 20
characters in length

d.Middle
Name
- the Subject's middle name

e.Last
Name
- the Subject’s last name, can be up to 20
characters in length

f.Subject
date of birth (DD-MMM-YYYY)

g.Gender–
the gender of the subject, can be male or female
(drop down list)

h.Height–
the height of the subject in either cm or inches.
Can be 3 numeric characters. Unit of measurement is user configurable
(see Subject
Data
Setup)

i.Weight-
the weight of the subject in either kg or lbs.
Unit of measurement is user configurable and also whether this field
can be
entered for Subject or not (see Subject Data Setup)

j.Population
group
– drop down list with predicted values associated
with each group. It is user configurable whether this field is entered
for
Subject's or not (see Subject Data Setup)

k.Smoking
Information - the Smoking status of the
subject. This can be
Smoker, Non-smoker or Ex-smoker via a drop down list

n.User
Field1–
Field added for extra information, The Label is
configurable (see Subject Data Setup).
The label can be up to 20
characters in length, the data associated with the label can also be up
to 20
characters in length.

o.User
Field2-
Field added for extra information, The Label is
configurable (see Subject Data Setup).
The label can be up to 20
characters in length, the data associated with the label can also be up
to 20
characters in length.

p.Attachments may also be saved
with the subject information

q.Pacemaker Detection – checkbox to
indicate whether or not the subject
has a pacemaker.

3.Click on the OK
button to save this subject to the database.

4.Click on the Cancelbutton to discard new subject and return to
the Spirotrac
desktop.

5.3.3
Editing a Subject

In order to edit a subject a user
may:

a.Right click on the subject in the
subject list on the left panel and
select edit subject

b.Select the subject from the
subject list on the left panel and select
the edit button in the subject demographics panel

c.Select the subject in the subject
list on the left panel and select the
Subject Details from the Edit menu

Click on the Cancel
button to undo the changes and return to the
Spirotrac desktop.

Note:
If the date of
birth, gender, height or population group of
the subject is changed, the predicted values for the subject shall be
recalculated.

5.3.4.
Selecting/Viewing a Subject

Select the subject in the subject
list on the left panel. The subject becomes the current subject. You
may
perform a Spirometry test on this subject, view his/her sessions,
select a
session for print and/or view his/her trend data.

The corresponding subject
demographics appear for that subject, with any
previously modified data appearing in green, and with all his/her
sessions
appearing in the lower left panel.

Note:
Click on to
expand tree and view sessions.

A trend of previous subject’s
sessions is displayed on the lower main
panel.

Note:
This trend
information is configurable.

5.3.5.
Finding a Subject

A search facility is available on
the main desktop for finding subjects.

Using the radio buttons, select
to search for a subject by either ID or
Last name

Enter the relevant search
information in the space provided and the
select the Search button

The search arrow will
automatically move to the first subject found
beginning with the information entered in the search field.

Note:
When searching by
ID if subject with matching Subject ID is
not found Spirotrac will search for a subject with a matching
Alternative ID

5.3.6.
Deleting a Subject

Select the Subject to be deleted
from subject list.

Right-click this Subject and
select Delete
Subject.

Select Yes
to delete the subject or No
to cancel.

5.3.7. Subject
Data Setup

Select Tools
-> Options from Main Menu
and then select Subject
Entry.

The user can configure the
following: -

a.Name
fields:The
user can select whether or not to enter any/all
of last name, first name and/or middle name as part of the subject
demographics

b.Unit
of Height: the user can select to enter
height in cm or
inches

c.Enter subject's
weight: the user
can select to enter weight as part of subject demographics or not. When
checkbox is ticked, weight can be entered/displayed/printed for
subjects.

d.Unit
of Weight:the
user can select to enter weight in kg or lbs

e.Alternative
Subject ID: the user can select to enter an
alternative
subject number as part of subject demographics. When 'Display/Report
On', this alternative number will be
displayed/printed for the subject.

f.Population
Group:
the user can select to enter Population Group as
part of subject demographics. When ‘Select
Population Group for Subject’is
ticked, then a
Population Group can be selected for a subject, and therefore,
displayed and
printed. When it is not ticked, it will not be possible to select a
population
group for a subject.

g.Extra
Subject Information:The
user can select to enter extra subject information
as part of the subject demographics dialog. When ‘Display
Subject Attachments’ is ticked the New Subject dialog will
contain a section allowing the user to associate attachments with the
subject.
The Extra Subject Information section also provides the user with the
ability
to add two additional fields to the New Subject dialog by ticking the
enabled
checkboxes for User Field 1 and User Field 2. Names can be specified
for each
of these fields in the spaces provided.

h.Smoking
Information:The
user can select whether or not to enter smoking
information as part of the subject demographics.

i.Notes:The
user can select whether or not to enter
comments/notes as part of the subject demographics

j.Validate
Subject Id:The
user can select whether or not subjects id’s are
to be validated for Sweden and Norway

k.Subject
ID Auto Generate: The user can select whether
Spirotrac will
automatically create a subject ID for new subjects.

l.
Alternative ID's: When enabled, the Subject ID Configurable label
and the ALT ID
Configurable label values defined here will replace the
standard Subject ID and ALT ID throughout the application and in
reports.

Click on theOK
button to
save the settings or Cancel
to ignore.

The user can choose to reset the
Subject Data entry settings by
selecting the Reset
Subject Settings button.

5.4 Predicted
Values

5.4.1. Population Group Setup

Select Tools
-> Options from Main Menu and select General.

In the Population
Groups & Regression Sets
section,
select the Managebutton.

To add a new population group, do the following:

Select the Newbutton, enter the name.

Select the corresponding Regression Set from the drop down list

Enter the correction factor (the
% to multiply the predicted value by)

Copy
Subjects and Tests - Both Subject and Test
data is transferred from the In2itive/Alpha Touch device to Spirotrac
and the
original data remains stored on the In2itive/Alpha Touch device.

Move
Tests - Test data is transferred from the
In2itive/Alpha Touch device to Spirotrac and the original test data is
deleted
from the In2itive/Alpha Touch device. This is the default mode.

Move
Subjects and Tests - Subject and Test data
is transferred from the In2itive/Alpha Touch device to Spirotrac and
both the
original subject and test data is deleted from the In2itive/Alpha Touch
device.

Connection
– indicate whether the asma-1 device
being used is of type USB, Serial or Bluetooth

Copy
Data - Test data is transferred from the
asma-1 device to Spirotrac and the original data remains stored on the
asma-1
device.

Move
Data - Test data is transferred from the
asma-1 device to Spirotrac and the original test data is deleted from
the
asma-1 device.

Click the OK button to save changes or
theCancelbutton to discard them.

On
selecting
Download Tests
Spirotrac connects to the appropriate device, downloads subject and
test
session data and presents a dialog containing a list of Subjects and
tests
downloaded. On selecting the save
option the Subject(s) selected and associated test sessions are saved
to the
Spirotrac database.

Selecting
Upload Subjectspresents
the user with a list of all subjects in the Spirotrac database. The
user can
then select the subject(s) that they wish to send to the Vitalograph
device. On
selecting the upload button these subjects are saved to the Vitalograph
device.
Test sessions are not saved.

If
Synchronisation mode is not selected in Optionsthe user can manually perform a sync by selecting Tools -> Device Downloads/Uploads
-> In2itive.

Selecting
Multiple Sync
allows the
user to
synchronise with multiple In2itive devices in sequential order. Each
In2itive
device is switched off on synchronisation completion.

5.6.
Exporting Data

Spirotrac provides a facility whereby the user can select
session(s) for subject(s) and export that data to CSV files.

To export session(s) for a subject:

Select the subject whose
session(s) are to be exported

Select Export
from the File Menu

Select the session(s) to be
exported from the list

Select/Enter the location for the
exported files

Select Export
to export the files

To export session(s) for multiple
subject(s):

Select Export
from the File Menu

Select a Subject from the
drop-down list

Select the session(s) to be
exported from the list

Repeat point b & c for
each subject whose session(s) are to be exported

Note: The software will require the user to confirm
whether or not sensitive personal identifying information should be exported. The
following warning message shall be presented:

Spirotrac provides a technical support menu function for the purpose of
provision of information to Vitalograph support to aid on customer
support queries.

To export Log Files:

Select the 'Help' menu item on the top of the screen.

On the drop down menu select 'Technical Support'.

Select the 'Export Logs' sub menu item.

5.7 Accuracy
Checking

5.7.1
Accuracy Checking in Spirotrac

All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend checking
the accuracy of lung function measuring devices at least daily
with a 3-L syringe to validate that the instrument is measuring
accurately.
The system should never be outside accuracy limits unless the measuring
device is
damaged or in a fault condition. In this event, see the corresponding
faultfinding guide. In normal use, calibration traceability
certification is
recommended as a part of the routine annual service.

ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped
into the spirometer from a syringe is within 3%.

Routine user accuracy checking on the measuring equipment should be performed

before the instrument has been
dismantled

after the instrument has been
dismantled

after cleaning

if damage is suspected

after annual maintenance checks

after adjusting calibration

if the flow-head has been dropped

The equipment used to perform the accuracy check should
itself be certified and traceable to national or international standards. All
measuring equipment should be checked for accuracy on an annual basis.
Although it is not a specified requirement, a routine annual service on this
equipment is strongly recommended.

Mandatory daily accuracy checking can be switched on and off as follows:

In
theTools
-> Options -> Generaltab.

When
this option is on, the user will not be
able to proceed to testing until an accuracy check has been performed
for that
day.

Note:

It
is recommended that the Vitalograph 3 Litre Syringe be used when performing an accuracy check. This has
an
accuracy of +/-0.5%.

5.7.2 Checking
Accuracy

Follow these steps to perform an
accuracy check.

Attach the Vitalograph device flow head to the precision syringe.

Select the Accuracy Check from the
Tools
menu. Alternatively select the Accuracy Check button on the main toolbar.

Enter the syringe reference and the syringe volume in L (1-9) in the dialog displayed.

Click
on the Check button and follow the instructions on the screen. (For the
Vitalograph Intrac device, see Note below for differences)

A
message shall appear prompting you to pump air through the
flow head in order to ensure that the flowhead is at ambient
temperature before an accuracy check is performed. Once you have pumped
air through the flow head click OK

Make sure the plunger is out fully and inject the syringe when prompted.

Press in the syringe with a smooth, firm stroke (not too slowly).

Follow the instructions on the screen and repeat step 6 and 7. Three repeatable syringe strokes are required.

If the accuracy is outside the
limits it is suggested that you perform another check before updating
the device.

If three consecutive strokes are
not reproducible within 3%, an error message is displayed.

It is possible for the user to
enter comments for an accuracy check on the results pop-up dialog.

It is possible to view and print
the Accuracy Check results at the end of the procedure. To re-check the
accuracy select the Re-Check
button.

Note: When performing an accuracy check using the Vitalograph Intrac device:

(step 6) ensure the plunger is fully pressed into the syringe before starting the accuracy check

(step 7) withdraw the syringe while maintaining the flow rate within the highlighted band on screen

5.7.3
Calibration update

If the accuracy is outside the
limits the user shall be presented with the option to Adjust the
calibration or not, only after a re-check has been performed. Select Yes
to adjust the calibration, Select No
to go back to result screen where a re-check can be performed if
desired.

If user selects to perform a
Re-Check, step 3 (3-10 as per Checking Accuracy)
will be performed again but this time the user will not be prompted to
re-check if a calibration adjustment is recommended.

If three consecutive strokes are
reproducible within 3%, but the overall % difference is greater than
25% the user shall not be allowed adjust the calibration. This may be
as a result of the following:

Faulty
equipment

Faulty
technique

It is possible for the user to
enter comments on the results popup dialog.

The user may view and print the
results at the end of the procedure.

5.7.4
Viewing/Printing accuracy log

Spirotrac maintains an accuracy
check log.

The accuracy check Log is updated
each time that an accuracy check is performed with the Pneumotrac in
Spirotrac.

Select the Accuracy
Check Log from the View
menu.

You will be prompted to select
the device ID from a drop down list, or alternatively, select All Devices to view the entire accuracy
log.

A screen is displayed with the
following information:

Date/Time.

Volume that
the device measured.

Percentage
difference from
syringe volume.

If the
accuracy was updated or
not.

User ID – the
user who performed
the check.

Temperature
that accuracy check
was performed.

The following extra information
is shown when the individual accuracy check is selected.

User ID – as
above.

Device ID –
the serial number of
the device.

The device
type

Syringe volume

Syringe
reference

User comment
if the device was
updated.

The log may be filtered by User,
device serial number, the date/time of the accuracy check. To remove
all filters and show all entries click theShow
Allentries
button.

Select the Report
icon to print the accuracy log.

You may view an individual
accuracy check and flow volume curves by double clicking on an
individual check or selecting one in the list and clicking on the View
button. The following window shall be displayed. The accuracy check
results may be printed by selecting the Report
button.

5.8.
Institute and Department

5.8.1
Viewing Institution or
Department Details

Select
Institution
Details
or Current
Department
in the Viewmenu.

The
institution or department information will be displayed.

Modifications
will not be allowed here.

Click
on the OK
button when finished.

5.8.2
Editing Institution or Department Details

1.In order to edit
institution or department details, select Institution
Details or Department Details
in the Editmenu.

5.8.3
Department Management

The Institute can have multiple
Departments, which are managed through the 'Department Management'
screen.

SelectTools
-> Department Management.

To
add a new department, select New,
enter department details and press the OK
button

To switch to another department,
select the department name from list and then pressSelectbutton.
When prompted for confirmation, select Yes
to switch departments or No
to keep the current department active.

Click on the Closebutton
to return to the main screen.

5.9
Audit Trail

5.9.1.
Audit Trail Codes

Note:
The user will only
be prompted to enter a reason for a
change on versions of the software which include audit trail activities
and
where 'User Annotation' below is indicated with a 'Yes'

<Regression Set Map, Population Group Name: New Population
Groups Name, Regression Set: Regression Set Name,
Correction Factor: Correction Factor>

No

AC18

Edit Population
Group

Field modified From <previous value>
To <updated
value>

Yes

AC19

Delete Population Group

<Regression Set Map, Population Group Name: name of the deleted
population group, Regression Set: name of the
regression set the deleted population group was mapped to,
Correction Factor: the correction
factor of the deleted population group>

Subject=[subject ID], Session Date/Time=[Date and time of the session which was
re-opened]

No

AC55

Re-Opening
VC Session

Subject=[subject ID], Session Date/Time=[Date and time of the session which was
re-opened]

No

AC56

Re-Opening
POST Session

Subject=[subject ID], Session Date/Time=[Date and time of the session which was
re-opened]

No

AC57

Re-Opening
AUDIOMETRY Session

Subject=[subject ID], Session Date/Time=[Date and time of the session which was
re-opened]

No

AC58

Export
Subject PII:

Subject
ID’s: [list of subject ID’s exported]

No

5.9.2.
Viewing/Printing the Audit Trail

Spirotrac records an entry in an
audit trail each time certain events occur within the application. For
a list
of these events see Audit Trail Codes. All Users can view and print
reports of
the Audit Trail.

Note:
This only applies
to versions of the software that include
this functionality.

SelectAudit
Trail from theView
menu.

All entries are sorted by
date/time initially. The User can change the sort order by clicking any
of the column headers.

The following information is
shown:

User ID – the user who performed
this action.

Date/Time - when the action was
performed.

Annotation Code – the type of
action performed. (AC code)

System Annotation – details of
the change will be recorded by Spirotrac e.g. previous and new values
etc.

User Annotation – the comment the
user entered at the time of the change if required. (Configurable)

The following extra information
is shown for individually selected audit entries:

The Entries can be filtered by
User , Date and/or Annotation Type. Click any of the corresponding
filter buttons and enter your criteria. The matching records will
automatically be shown. To remove all filters and show all entries
click the Show All entries button .

The current entries can be
printed by clicking the Report button . Note: Only the entries
displayed on screen will be printed i.e. if data is filtered by a user
ID, then only the entries belonging to that user id will be printed on
the report.

5.10
Reporting and Printing

5.10.1.
Printer Setup

Spirotrac offers a facility for
printing various reports such as audit trail reports, accuracy log
reports,
trend reports and test session reports. Spirotrac shall save the
current
selected printer and it shall be possible to change printer setup from
within
the application.

Select Printer
Setup from the File
menu.

Select the desired printer and
click OK.

Note: When the COMPACT is
not connected to the
network, a USB flash drive shall be required to save report to PDF.

5.10.2.
Report configuration

Spirotrac provides the user with
the
option to configure reports as follows:

Select Tools
-> Options and then Reports.

The user can enter/change the
headings to appear on VC/FVC reports (Report Header) and Post Test
Reports (Post Report Header)

The user can select whether the
application will print spirometry reports in full, Full
Report format, or limit them to
one page, One
Page Report format.

When theFull
Report is selected, the user can
configure which tests will be printed on the report. The following
print options are available:

Best Summary - Print the ATS/ERS Best Test
only

All Tests - Prints all tests from the session, up to a max of 8, in order of test

An Economode option is available
for selection. When selected, all test session reports printed will
have any shaded areas removed.

The
user can select whether the report shall contain the following
information: LLN, Graphs, Session Comments, Session Interpretation and
reference graphs and data

The
user can select whether or not to print rejected tests on the report

The user can choose to reset the
Report configuration settings by selecting the Reset
Report Settings button.

Select OK
to save change or Cancel
to discard.

Note:
When the One Page Report is printed, only the first 7 enabled
parameters are printed on the report.

Ensure that the tubing connectors are clear of
obstruction or dirt and that they are inserted fully

Ensure the tubing is not kinked or squeezed

Ensure flow-head is clean

Problem
Fault Symptoms:

Test begins automatically

Volume accumulates automatically without the
subject blowing

Very small VC or FVC test displayed

Possible
Causes:
(In probable order)

Flowhead and/or tubing not stationary at the start
of test. Hold them steady until the ‘Blow Now’ prompt appears.

Return to Main Menu and re-enter the test routine

5.15.1 Technical Support Menu Item

Spirotrac provides a technical support menu function for the purpose of
provision of information to Vitalograph support to aid on customer
support queries. The log files will be saved as a single zip file.

To export Log Files:

Select the 'Help' menu item on the top of the screen.

On the drop down menu select 'Technical Support'.

Select the 'Export Logs' sub menu item.

A save as dialog will be shown, chose the destination for the log files, select the save button.

Note: When running Spirotrac on the Compact device, the user will only be allowed to save the log files on a removable storage device.

5.16
Database Management

5.16.1
Select a new database

Spirotrac provides the ability to create a new database and
select it for use through the ‘Database Management’ screen.

Select Tools -> Database
Management.

To select a new database
go to the 'Select' tab and do the
following:

a.Select/Enter the name or I.P.
address of the SQL Server host

b.Select/Enter the SQL Server
instance name

c.Select the desired authentication
mode from the drop down list and enter
the user login and password if SQL authentication and then select the refresh button

d.Select the name of
the database from the drop down list and
select Apply

e.You shall be prompted to restart
Spirotrac.

Note: Upon re-start,for new databases only, Spirotrac
shall prompt for database details setup. See Spirotrac
Database Setup
for
more information.

To create a new database:

Select the Create tab within
the Database Management screen.

Select/Enter the database
connection details as above.

Enter a name for the new database
and select Create.

5.16.2
Backup or Restore a Database

Spirotrac provides the ability to backup and restore
databases through the Database Management
screen.

Select Tools -> Database
Management.

5.16.2.1 Backup

1.Click
the Backup tab within the Database
Management screen.

2.Select
the database to backup and enter a location to store the backup to.

3.Click
the Backup button.

4.The
user will be notified when the database backup is complete.

5.16.2.2 Restore

1.Click
the Restore tab within the Database
Management screen.

2.Enter
the new database name for the backup to be restored under.

3.Select
the file which will be restored.

4.Click
the Restore button.

5.The
user will be notified when the database is restored.

5.16.3
Database merge

Spirotrac provides the ability to
merge a source database with a destination database through the
‘Database
Management’ screen. Data from the source database shall be copied into
the
destination database. The source database shall remain unchanged.

Note:
Performing
a database merge is not recommended for larger databases. The merge
should be
restricted to databases with no more than 1000 subjects/8000 blows.

The merge is designed to be performed in
one of the following ways

Local database to local database

Local database to network database

Network database to network database using sql authentication

Note: You cannot merge
from a network
database to a local database.

Before performing a merge, you should note the following

It
is advisable to perform a backup of the destination database prior to
performing a merge.

Close
any open sessions and ensure that you are the only user currently
logged on to
Spirotrac accessing both the source and destination databases.

Ensure
the current Spirotrac user has access to the source and destination
database
and has the correct privileges. Only system and site admin users can
perform a
merge.

Review
the Subject numbers to avoid duplicating subjects. Note: when duplicate
subjects are created during the merge, they can be identified with the
prefix
‘DUP:’ in the destination.

Click the Settings tab within the
Database Management screen of Spirotrac.

To enable automated database
backups, check the tickbox Perform
automatic backup of current local database on close of Spirotrac.
To
disable automated database backups, uncheck this tickbox.

5.17.
Vitalograph Spirotrac Fusion

On selecting the Send
Sessions,
Send
All Unsent
options from the File menu or by selecting the Send
sessions to over-read
button the user will be presented with a dialog informing them that the
Vitalograph
Fusion Quality Assured Spirometry System is
not currently
enabled. On selecting Yes they will
be presented with a dialog informing them about the system. This dialog
contains a link that allows the user to contact Vitalograph regarding
more
information about Fusion.

5.17.1.
Fusion

Vitalograph
Spirotrac Fusion is an integrated, easy to use Quality Assured
Spirometry System providing
expert over-reading of spirometry in primary care, occupational health,
or post-training
environments. The expert over-readers can be your own experts or
provided as an
optional service by Vitalograph.

Spirotrac
Fusion supports you in the delivery of good and cost effective clinical
governance by providing assurance, backed up by hard data, that the
quality of
your entire group’s spirometry meets acceptable standards. Where an
individual
operator’s spirometry quality is less than optimum, this automated
feedback
data enables identification of specific training needs by the project
manager.

Requiring
only Internet access or a mail client, Spirotrac Fusion is very easy to
use:

2.When
enabled, to set a session as a reference
session select Reference -> Set
as
reference when in the main testing screen.

3.Alternatively,
when in the Visits list for a
subject, right click on the test that is to be
set as the reference.

5.19
Health Level 7 Interface

Health Level 7 (HL7) is an
internationally recognised
standard for the exchange and management of electronic healthcare
information.

HL7
provides an interface between Electronic Medical Record
(EMR) systems and Spirotrac and automates the transfer of order
messages and
associated subject demographic data to Spirotrac, while also providing
an
interface for the transfer of test results from Spirotrac to the EMR
system.

More
information about using the HL7 interface can be
obtained from technical
support at +353 65 6864082 or email spirotrac@vitalograph.ie

5.19.1
Changing Health Level 7
(HL7) Settings
within Spirotrac

Click
on Options
beside the HL7 Enabled checkbox to
edit settings for PDF report generation. This will display the HL7
Options
window.

From
within the HL7 Options window generation of
the PDF report can be enabled by ticking the Output
PDF Report with Export checkbox.

The
location of the PDF file can be changed by
editing the PDF File Location field
within the HL7 Options window.

The
label that will display in the Return EMR
Data window for EMR Request Messages can be modified using the Message Checkbox Display Text control.
The fields appearing in the right window define the information that
will be
included in the label. By default Message Date/Time is used. Fields can
be
moved between the left and right window by clicking the arrow buttons.

5.19.2
Identifying Subjects with Pending Requests from an EMR System

Upon receiving a test request
for a subject from an EMR system over HL7, Spirotrac will flag this
subject in
the Subject List with an ‘e’

Select View
-> Subject View -> EMR Subjects in the File
Menu to
display only those subjects with a pending test request from an
EMR system.

Select View
-> Subject View -> Non EMR Subjects in the File
Menu to display only
those subjects who do not have a pending test request from an EMR
system.

To
view all subjects, select View ->
Subject View -> All Subjects
in the File Menu.

5.19.3
Editing Subject Demographics before EMR Requested Testing

The subject’s
demographics can be updated before performing the EMR requested testing.

Select the subject from within the Subject
List and click Edit from
within the Subject Demographics
window.

Update
the form information as required and
click OK to save the changes. Click
Cancel to exit the form without
saving.

5.19.4
Transmitting Sessions for EMR Subjects

When
testing is complete, the test session can be returned to the EMR system.

Select the EMR subject.

From within the Subject Demographics window,
click Return EMR

Tick
the EMR Request message(s) for which the
session is being sent. To send an unsolicited message, i.e. a message
not
corresponding to any EMR Request, tick Send
Unsolicited Message and select the appropriate test type.

Tick
the session data which is to be sent.

Click
Return
Itemsto transmit the
session
data for the selected EMR request(s) or click Close
to exit the Return EMR Data window without transmitting the
session data.

5.19.5
Transmitting Sessions for Non-EMR Subjects

Test session data can also be
returned for subjects that do not have a pending EMR test request. In
this
case, only an unsolicited message can be returned to the EMR.

Select the non-EMR subject.

From
within the Subject Demographics window,
click Return EMR

To
send an unsolicited message, i.e. a message
not corresponding to any EMR Request, tick Send
Unsolicited Message and select the appropriate test type

Tick
the session data which is to be sent.

Click
Return
Items to transmit the session data for the selected EMR
request(s) or click
Close to exit the Return EMR
Data
window without transmitting the session data.

5.19.6

Transmitting Sessions automatically

Test
session data can also be returned automatically without a pending EMR test
request. To configure Spirotrac to automatically return unsolicited messages:

Perform an FVC session and when the session is
closed (e.g. on selecting another subject), the session data shall be
transmitted.

5.19.7
Viewing the HL7 Logfile

To view or print the log of all HL7 messages sent and received:

Select View
-> View and Print HL7 Logs from the Main Menu. This
will display the HL7 View and Print dialog window. Note that this
option only appears when HL7 is enabled.

Select the logfile from the dialog and click Open. This will
open the selected file in a new window.

To print the log, select Print Log from the
menu. To close the log, click the X
in the top right corner of the window.

5.20
Interpretation Display

Spirotrac can provide algorithm based interpretations of
test results. The interpretations are provided for consideration by
trained
physicians in conjunction with other relevant medical data and are not
intended
to be used as the sole indication for subject diagnosis.

It is possible to override the algorithm based interpretation with a
user interpretation. To do this, click the Edit button below
the 'User Interpretation' textbox on the Interpretation tab and enter
the new interpretation.

5.21 Custom Report Template Selection

Spirotrac
provides the option for the user to select different FVC Test
Spirometry report templates, other than the standard Spirotrac reports.

To activate this feature and choose templates:

Select Tools
-> Options -> Reports -> Custom Report Settings

When the Custom Report Options window is shown, tick the
relevant Pre and Post check boxes to
activate the required report.

To
select the available report templates for the Pre or Post FVC test
click the "..." button, to the right
hand side of the relevant check box.

6. Testing
Using Spirotrac

6.1.
Spirometry Testing

Testing
may be done either in the sitting or
standing position. The standing position may not be appropriate in some
circumstances, such as in hospitals where many subjects may not be able
to
tolerate the standing position, especially when making forced
manoeuvres. If
the standing position is used, an appropriately shaped chair should be
placed
behind the subject so he/she can quickly and easily be eased into a
sitting
position if he/she becomes light-headed during the manoeuvres. The
posture type
must be selected prior to testing (see Checks to Make before Performing
VC, FVC
and Post Tests) For recommended methods of spirometry testing refer to
the
Vitalograph website (see contacts section at the top of this manual).

During testing:

If the Pneumotrac/In2itive is
connected correctly, the correct COM port is selected, and the device
is within temperature operating limits, the FVC test screen shall be
displayed.

If the device is not within
temperature, testing may still continue but results may not be valid.
This will be indicated by displaying a warning message to the user.

If the test screen is left idle
for two minutes or more, Spirotrac will suspend the test.

The maximum number of blows that
a subject should perform in any one session is eight.

You may leave the test screen at
any time by selecting Return.
This brings you back to the main screen, but the test session remains
open. Selecting the test button again returns you to the test screen,
and testing can continue.

A test session will remain open
until one of the following occurs, and at that point you will be
prompted whether or not you wish to close the session:

Selecting a
Different Subject

Selecting the
Post Mode testing

Closing
Spirotrac

Add Subject

Editing a
Subject

Performing a
Calibration Update

Performing
Department Management

Changing
Password

Performing
Database Management

Invoking the Device Downloads/Uploads

Selecting
Tools->Options->Advanced

Switch User

Send Sessions

Send All
Unsent Sessions

Edit
Institution

Edit
Department

Changing
Device

6.1.1.
Checks to Make before Performing VC, FVC and Post
Tests

Before
commencing a test routine, check that the options for testing are set
up
correctly as follows:

Check
that the Vitalograph spirometer device is connected correctly. (See the
appropriate Connecting the Vitalograph device to your PC)

Again, wait for the ‘BLOW NOW’
message to appear on screen, before performing the next blow.

After
each blow, the user shall be prompted to Accept or Reject the test.

It
shall be possible for the user to Accept or Reject the test at any time
using the User Acceptability drop down list. Changing the acceptability of
a test will automatically update the best test information.

When all blows are complete,
click on the Return
button to return to the previous screen.

6.1.3. Performing
FVC Testing

Select a subject by clicking on
the Subject in the subject list on left hand side of main screen.

Once the required subject has
been selected from the list, select FVC
from the Test
menu or click on the FVC Test button

Wait for the ‘BLOW NOW’ message
to appear on screen before beginning the test.

After each blow a quality summary
window is displayed. The test acceptability and session quality for the
test performed is displayed to the user (seeTest Quality Information).

It is possible for the user to
Accept, Reject or keep the automatic interpretation for the test at any
time using the User Acceptability drop down list. Changing the
acceptability of a test will automatically update the best test,
reproducibility and quality information.

Session information, Quality
information, Acceptability and Usability information can be viewed at
any time during testing by selecting the relevant tab on the test
screen. The Parameters tab contains the parameter values and also
includes System Acceptability information and User Acceptability
information. The Test QA tab contains information on the status of all
test acceptability criteria for each test. The Info tab contains
information about the overall session such as Session Grade
information, Repeatability information, Session Comments and
Interpretations.

The next test can be performed
once the ‘BLOW NOW’ message re-appears on screen.

6.1.3.1. Re-open
a closed spirometry session and continue testing

Select
a subject by clicking on the Subject in the subject list on left hand side
of main screen.

Once
the required subject has been selected from the list, select the required
VC, FVC, or Post FVC session to be re-opened. Note: This session
must have been performed on the same calendar day and cannot be an FVC
session which already has a Post session associated with it.

Select
the appropriate test button , VC for a VC session or FVC for an FVC
session (pre or post)